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Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System (Chronic II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853645
First Posted: March 2, 2009
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
Primary objective is to evaluate the safety and performance of the implanted S-ICD system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.

Condition Intervention
ACC/AHA/HRS Class I and II Indications for ICD Implantation Device: Subcutaneous Implantable Defibrillator (S-ICD) System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Initial Chronic Human Validation Study: Subcutaneous Implantable (S-ICD) System

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Induced VF conversion efficacy [ Time Frame: 30 days ]

Enrollment: 6
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-ICD System
Single-arm with 6 patients implanted with an S-ICD System
Device: Subcutaneous Implantable Defibrillator (S-ICD) System

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • replacement of an existing transvenouse ICD system
  • ACC/AHA/HRS Class I or II indications for ICD implantation
  • Age >= 18 years
  • Appropriate pre-operative ECG as measured with a specially developed template

Exclusion Criteria:

  • Subjects unable or unwilling to provide informed consent
  • Any condition which precludes the subject's ability to comply with the study requirements
  • Remales who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
  • Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
  • Patients with a serious medical condition and life expectancy of less than one year.
  • Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
  • Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
  • Patients with chronic renal failure, i.e. with a creatinine level of >2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be <= 3mg/dl
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853645


Locations
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 8140
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Stephen O'Connor, PhD, Hon FRACP Boston Scientific Corporation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00853645     History of Changes
Other Study ID Numbers: DN-11398
First Submitted: February 27, 2009
First Posted: March 2, 2009
Last Update Posted: February 16, 2017
Last Verified: February 2009